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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K082720
FOIA Releasable 510(k) K082720
Device Name TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
Applicant
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Applicant Contact STACY ABBATIELLO KLUESNER
Correspondent
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Correspondent Contact STACY ABBATIELLO KLUESNER
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received09/17/2008
Decision Date 11/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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